Oscar Varicose Vein Treatment (CG004) Form

The lower extremities contain a system of veins that bring blood back towards the heart. This venous system consists of superficial veins (great and small saphenous veins) and deep veins (femoral and popliteal veins), which are connected by a series of perforator veins. These veins have small one-way valves in them, which normally function to prevent the blood from flowing backwards. When these valves fail to function as intended, the blood can flow in the opposite direction and pool in the superficial veins. The condition associated with this venous reflux or insufficiency is called varicose veins, and it is a relatively common condition that may affect 10-30% of the population. Symptoms of varicose veins can range from visible varicosities to more severe symptoms such as ulceration and hemorrhage. Treatment is usually conservative and consists of leg elevation and compression stockings. In many patients, symptoms can be alleviated with conservative management, which may include compression, analgesics, NSAIDS, exercise, weight loss, and elevation of extremity. However, when conservative treatment fails or the symptoms warrant further intervention, surgical procedures may be indicated. The Plan considers treatment of varicose veins in the setting of non-cosmetic, persistent symptoms of venous disease medically necessary. Findings of venous insufficiency on a recent ultrasound examination of the veins in the leg must be documented. The specific indications of medical necessity are outlined below. Please check your plan coverage for varicose vein treatment benefits. 1 Definitions “Endovenous Mechanochemical Ablation” is a technique that uses a combination of sclerotherapy and mechanical disruption of the venous walls. “Perforator Veins” are veins that connect the superficial veins to the deep draining veins. “Phlebectomy” is a technique in which the varicose vein is removed through numerous tiny cuts made in the skin. Types of phlebectomy include, but are not limited to, the following: - - “Hook Phlebectomy” or “stab avulsion”or “stab phlebectomy” is where a small hook-shaped device is inserted through the cut in the skin to remove the vein “Transilluminated powered phlebectomy” is performed with a bright light to illuminate the vein and then suction is used to remove the targeted region. “Sclerotherapy” is an injection of a chemical into the vein that causes fibrosis (scarring) and permanent occlusion of the vessel. Types of sclerotherapy include, but are not limited to, the following: - - - “Liquid Sclerotherapy” is the traditional method of sclerotherapy where a liquid agent is injected into the vein “Foam Sclerotherapy” is similar to liquid sclerotherapy but instead uses a foam substance rather than a liquid, which may allow for more rapid treatment and that of larger areas. “Echosclerotherapy” uses ultrasound to guide the needle to the appropriate vein, often used for deeper or difficult to visualize veins. “Subfascial Endoscopic Perforator Surgery (SEPS)” is surgical procedure used to treat incompetent perforator veins where the veins are divided and clipped as treatment. “Thermal Ablation” is a technique that uses laser light or radiofrequency energy to generate a temperature high enough that damages the vein wall and subsequently occludes the vessel. “Vein Ligation/Stripping” is a surgical procedure where the incompetent vein (usually the great saphenous vein) is surgically tied and then pulled out from under the skin through an incision. Clinical Indications Open Venous Surgery (Stripping/Ligation) and Endovascular Thermal Ablation (Radiofrequency or Laser) (Please check your plan coverage for varicose vein treatment benefits) 1. For the Great Saphenous Vein, Accessory Saphenous Vein, or Small Saphenous Vein, The Plan considers initial open venous surgery or endovascular thermal ablation medically necessary when ALL of the following criteria are met: a. Varicose veins result in at least one of the following symptoms: i. ii. Recurrent bleeding from a superficial varicose vein; or Ulceration secondary to venous stasis; or 2 iii. The following symptoms despite a 3-month trial of adherence to conservative measures such as leg elevation, exercise, compression stockings, and analgesics or documentation as to why a 3-month trial of conservative management is not indicated: 1. Pain, edema, leg heaviness or cramps that interfere with activities of daily living; or 2. Persistent or recurrent superficial thrombophlebitis. b. Duplex ultrasound study of the legs within the last 12 months confirming reflux, defined by at least 0.5 seconds of retrograde flow, at a site proximal to the anticipated location of therapy; and c. No evidence of acute deep venous thrombosis on duplex ultrasound or other contraindications to the therapy, including but not limited to local infection or systemic infection, advanced peripheral arterial disease, or advanced collagen vascular disease. 2. For Perforator Veins, The Plan considers initial surgical ligation (i.e., SEPS procedure) or endovascular thermal ablation medically necessary when ALL of the following criteria are met: a. Duplex ultrasound study of the legs within the last 12 months confirming reflux, defined by at least 0.5 seconds of retrograde flow, at a site proximal to the anticipated location of therapy; and b. Vein diameter of at least 3.5 mm as measured by duplex ultrasound study; and c. Any reflux identified in superficial saphenous veins has been eliminated; and d. Located beneath a healed or open venous ulcer; or e. The ulcer has persisted despite a 3-month trial of adherence to conservative measures such as leg elevation, exercise, compression stockings, and analgesics or documentation as to why a 3-month trial of conservative management is not indicated. Endovenous Chemical Ablation (Liquid Sclerotherapy, Foam Sclerotherapy, Echosclerotherapy) (Please check your plan coverage for varicose vein treatment benefits) The Plan considers initial treatment for varicose veins via endovenous chemical ablation medically necessary when ALL of the following criteria are met: 1. One of the following two treatment modality criteria is met: a. After failure of endovenous thermal ablation or open venous surgery: i. endovenous chemical ablation is a standalone or follow-up treatment modality for great saphenous, small saphenous, accessory saphenous and perforator veins (measuring greater than 3.5 mm in diameter by ultrasound); or b. For veins that are not amenable to endovenous thermal treatments or open venous surgery: i. endovenous chemical ablation is a concurrent or follow-up treatment modality for great saphenous, small saphenous, accessory saphenous and perforator veins (measuring greater than 3.5 mm in diameter by ultrasound); and 2. Varicose veins result in at least one of the following symptoms: 3 a. Recurrent bleeding from a superficial varicose vein; or b. Ulceration secondary to venous stasis; or c. The following symptoms despite a 3-month trial of adherence to conservative measures such as leg elevation, exercise, compression stockings, and analgesics: i. Pain, edema, leg heaviness or cramps that interfere with activities of daily living; or ii. Persistent or recurrent superficial thrombophlebitis. 3. Duplex ultrasound study of the legs within the last 12 months confirming reflux, defined by at least 0.5 seconds of retrograde flow, at a site proximal to the anticipated location of therapy; and 4. No evidence of acute deep venous thrombosis on duplex ultrasound or other contraindications to the therapy, including but not limited to local infection or systemic infection, advanced peripheral arterial disease, or advanced collagen vascular disease. Polidocanol Endovenous Microfoam 1% (Varithena) (Please check your plan coverage for varicose vein treatment benefits) The Plan considers initial treatment for varicose veins with Polidocanol Endovenous Microfoam 1% medically necessary when ALL of the following criteria are met: 1. After failure of endovenous thermal ablation or open venous surgery: a. Polidocanol Endovenous Microfoam 1% is either a standalone, follow-up, or concurrent treatment modality for great saphenous veins or accessory saphenous veins; and 2. No more than 3 injections (5 mL per injection,15mL total) per session (one or both legs); and 3. Varicose veins result in at least one of the following symptoms: a. Recurrent bleeding from a superficial varicose vein; or b. Ulceration secondary to venous stasis; or c. The following symptoms despite a 3-month trial of adherence to conservative measures such as leg elevation, exercise, compression stockings, and analgesics: i. Pain, edema, leg heaviness or cramps that interfere with activities of daily living; or ii. Persistent or recurrent superficial thrombophlebitis; and 4. Duplex ultrasound study of the legs within the last 12 months confirming reflux, defined by at least 0.5 seconds of retrograde flow, at a site proximal to the anticipated location of therapy; and 5. No allergy to polidocanol, no evidence of acute deep venous thrombosis on duplex ultrasound, or other contraindications to the therapy, including but not limited to local infection or systemic infection, advanced peripheral arterial disease, or advanced collagen vascular disease. Stab Avulsion / Hook Phlebectomy/ Stab Phlebectomy The Plan considers initial treatment for varicose veins by Stab Avulsion, or Hook Phlebectomy, or Stab Phlebectomy medically necessary when ALL of the following criteria are met: 1. Visible Superficial tributary varicosities, accessory, or perforator veins that are 3 mm or greater in diameter; and 4 2. Performed concurrently or in conjunction with or after another treatment method for varicose veins as listed above in the guideline (e.g., vein stripping, thermal or chemical ablation); and 3. Reflux, defined by at least 0.5 seconds of retrograde flow, confirmed by ultrasound or duplex ultrasound study of the legs within the last 12 months proximal to the incompetent junction that is also being treated; and 4. Saphenous venous insufficiency symptoms causing functional impairment to activities of daily living, including 1 or more of the following: a. Bleeding, recurrent bleeding, or ruptured superficial varicose veins; or b. Leg edema (swelling); or c. Leg fatigue or heaviness; or d. Leg pain or cramps; or e. Persistent or recurrent superficial thrombophlebitis; or f. Persistent or recurrent venous stasis ulcer; or g. Skin changes (e.g., hemosiderosis, lipodermatosclerosis); and 5. No other exclusions listed under Experimental or Investigational / Not Medically Necessary; and 6. No lymphedema or severe peripheral edema in region of procedure; and 7. No evidence of acute deep venous thrombosis on duplex ultrasound or other contraindications to the therapy, including but not limited to local infection or systemic infection, advanced peripheral arterial disease, or advanced collagen vascular disease. Continued Care Criteria for Continuing Treatment After Initial Trial Open Venous Surgery (Stripping/Ligation), Endovascular Thermal Ablation (Radiofrequency or Laser) The Plan considers repeat procedure medically necessary when the following criteria are met: 1. The member continues to have symptomatic varicose vein(s) after treatment with ≥0.5 seconds of retrograde flow (for perforator veins ≥3.5mm diameter). Endovenous Chemical Ablation (Liquid Sclerotherapy, Foam Sclerotherapy, Echosclerotherapy) The Plan considers repeat procedure medically necessary when ALL of the following criteria are met: 1. The member continues to have symptomatic varicose vein(s) after treatment with ≥0.5 seconds of retrograde flow (for perforator veins ≥3.5mm diameter); and 2. No more than 3 sessions per vein field in total. Polidocanol Endovenous Microfoam 1% (Varithena) The Plan considers repeat procedure with Varithena medically necessary when ALL of the following criteria are met: 1. The member continues to have symptomatic varicose vein(s) after treatment with ≥0.5 seconds of retrograde flow (for perforator veins ≥3.5mm diameter); and 2. No more than 3 sessions per vein field in total; and 5 3. A minimum of 5 days have passed since the last session. Stab Avulsion / Hook Phlebectomy/ Stab Phlebectomy The Plan considers repeat procedures medically necessary when ALL of the following criteria are met: 1. The member continues to have symptomatic varicose vein(s) after treatment; and 2. The procedure is performed no more than a total of three sessions (dates of services) per leg; and; 3. A minimum of 10 days since last session; and/or 4. If a request is beyond three total sessions per leg, the member must meet initial treatment criteria and a 3-month trial of adherence to conservative measures such as leg elevation, exercise, compression stockings, and analgesics or documentation as to why a 3-month trial of conservative management is not indicated. Experimental or Investigational / Not Medically Necessary 1. The treatment of asymptomatic varicose veins is considered cosmetic, not medically necessary. 2. The treatment of small veins, telangiectasias, and spider veins (reticular veins) measuring less than 3 mm by any mechanism is not medically necessary, as such small veins are cosmetic problems and do not typically cause pain, bleeding, ulceration, or other medical problems. These include but are not limited to: a. Asclera polidocanol injections b. Photothermal sclerosis (phototherapy, e.g., PhotoDerm, VascuLight, VeinLase) c. Transdermal laser d. VeinGogh Ohmic Thermolysis System 3. The following treatment options are not covered, as they are considered experimental and investigational as there is insufficient evidence in the peer-reviewed literature documenting their effectiveness and long-term outcomes relative to established therapies: a. Cyanoacrylate glue occlusion (medical adhesive, VenaSealTM Closure System) b. Endovenous Mechanochemical Ablation (ClariVein® Catheter, MOCA, MCEA, MEECA) c. Transdermal laser d. SEPS for the treatment of venous insufficiency associated with post-thrombotic syndrome e. Coil embolization f. Any type of cryosurgery or cryoablation or cryostripping g. Endoluminal radiofrequency, thermal, or laser ablation of varicose tributaries or as an alternative to SEPS for perforator veins. h. Transilluminated Powered Phlebectomy (TIPP) 4. Additional duplex ultrasound when used to monitor response to treatment within 90 days of procedure is not covered separately as it is considered integral to the original procedure. 6